This invention relates to a suture package which permits direct dispensing of a sterile surgical suture with or without a needle attached. More specifically, to a suture package having a bell shaped configuration that can be torn from a tear notch across the lower portion of the bell shape to expose a looped end of the sterile surgical suture. A suture is a strand of material suitable for suturing, with or without an attached needle, used for ligating or other surgical procedures.
The packaging of many commercial products is essential to the proper and use of the product and thus forms an integral part of the overall product design. The significance of packaging is most evident in the packaging of surgical sutures. It is essential that the package protect the product and maintain sterility throughout its period of potential use. Sutures may be stored in hospitals for several years, although the usual storage time is much shorter. It is essential that the package provide rapid and positive means of identification and release the product undamaged ready for use by the surgeon. There are many sizes of sutures, and many materials of construction such as catgut or polyglycolic acid for absorbables, silk, cotton, nylon, dacron, polyethylene, polypropylene, stainless steel, insulated stainless steel and other materials for use as non-absorbables. There are several different needle types in common use including pointed straight, pointed curved, three cornered straight, three cornered curved, curved both regular and reverse cutting, and needles with side cutting edges of various types. The variations and combinations of each of these to meet the preference of many surgeons for different operative procedures means that the suture manufacturer needs to supply different suture combinations running into the thousands. The importance of positive identification and efficient, economical packaging can thus be readily appreciated.
It is also important to provide convenience to the use and limit the risk of accidently enclosing foreign items in the patient by limiting the number of extraneous packaging materials associated with use of the product in the operating theater. A count is often kept to ensure that each item is accounted for and removed from the operating field. Considering the ramifications of enclosing such material in the patient accidently during surgical procedures, it is obviously essential to minimize this hazard.
It is also important that the surgical package properly present the suture suitably oriented within the package so that the user can rapidly and reliably have access to the suture end, either needled or non-needled, in the proper position for dispensing from the package.
It is important also, to provide a standard packaging format for all multiple suture materials to limit confusion on the part of the user during surgical procedures. Over the years various package styles have evolved that have detracted from user convenience and operating room efficiency. For purposes of storage in the hospital as well as economy of manufacture, it is highly desirable that as many suture combinations as feasible be packaged in a minimum number of different package styles and shapes and storage units. It is quite common to package 3 dozen identical sutures in a box. It is convenient to have most of the boxes about the same size and shape, so that the hospital may store them most conveniently. It is also convenient from the manufacturers stand point to be able to reduce his inventory of box sizes and to be able to use the same components for the maximum number of suture combinations in the product line.
It is essential that a package containing a needled surgical suture protect the suture from contact with the sharp point or cutting edge of the needle which could partially cut or fray the suture.
These requirements are so rigorous and of such importance that many different package designs have been tried. Applicant is not aware of any prior art reference which, in his respective judgment as one skilled in the suture packaging art, would anticipate or render obvious the suture package of the instant invention; however, for the purpose of fully developing the background of the invention and establishing the state of the requisite art, the following references are set forth: U.S. Pat. Nos. 3,939,969; 3,357,550; 3,221,873; 3,202,273; and 2,949,181. These patents are incorporated herein by reference. Generally, these patents disclose a surgical suture packaged in an outer plastic or foil strippable envelope. Contained in the strippable envelope is an inner or pouch which is sterile. The suture strand has been formed into various retainers, labels, or reels, within the inner envelope.
The suture is normally prepared for the surgeon by stripping the outer envelope and transferring the inner envelope by sterile forceps, or by projecting it across a sterile barrier, into the sterile areas of the operating room. The inner envelope is opened at the time of use.
The inner envelope and suture retaining label of the present invention for a needled or non-needled suture have advantages over these prior art patents. After tearing the inner envelope of the present invention, the suture retaining label is used for direct dispensing of the suture without extracting the label from the inner envelope. Access to the suture is provided by a loop at the suture and which is pulled after tearing the inner envelope. The suture unwinds from its array within the package upon pulling the loop.
Because the inner envelope, the torn portion of the inner envelope, and the suture retaining label remain together after opening, the proliferation of packaging materials within the immediate area of the operation or other surgical procedure is reduced. In most operations and surgical procedures, the materials used for the operation or surgical procedure are counted subsequent to the operation or surgical procedure. The label, the inner envelope and the torn portion of the inner envelope of the present invention provide a readily identifiable and countable package.
Further, the size of the needle and the type of suture strand can be printed on the suture retaining label. This provides ready identification in a surgical procedure where more than one size and type of suture is used. Also, because the inner envelope is clear, the size and type of suture and needle can be confirmed visually before the suture is dispensed.
Perhaps of most importance and the greatest advantage to the package of the invention is the bell shaped configuration of the top portion of the inner envelope. The bell shaped seal allows more surface area for grasping by the hand. When the inner envelope contains a liquid e.g., a conditioning liquid or softening solution, the bell shaped configuration eliminates or minimizes the squirting of the liquid or solution by hand pressure on the envelope. The bell shaped configuration also gives a "bottle effect" to the package. The wider seal gives more rigidity and support to the top of the package even after opening. This tends to keep the opening closed. Also, because there is a narrower opening, the flow of the liquid is restricted. Also, the narrower opening tends to retain the liquid within the larger end of the package after it is opened.
The Bell shaped configuration is unusual in the heat sealing art generally and in suture packaging specifically. In the heat sealing art, a contoured shape can be more difficult to fabricate because of closer tolerances in the tool design of the sealer, and in sealing pressure applied.
The usual configuration in suture packaging is rectangular with the remaining side being a chevron or "cathedral roof" configuration. See, e.g., U.S. Pat. Nos. 3,357,550; 3,256,981 and 2,949,181 which are incorporated herein by references.
Perhaps of equal importance to the bell shaped configuration is the direct dispensing of the suture strand from the package of this invention.
In the prior art, the suture strand has been contained in or on various retainers, labels, or reels. The suture is dispensed by opening the package, e.g. by tearing or peeling, pulling out the wrapped suture, and then unwinding or separating the suture from its wrapper.
The package of this invention is direct dispensing. Upon opening the package, the suture is directly removed from the package without having to unwind or separate the suture from its retainer label. This has the advantage of saving time, which in a surgical procedure can be of extreme importance. Another advantage of the direct dispensing package of this invention is that the suture is directly dispensed from the end. The suture is thus readily available for immediate use, either by hand or by use of a needle holder. Still another advantage is that the suture retainer label is retained in the package after direct dispensing of the suture. This has the advantage of reducing the amount of loose packaging materials in the surgical area. Still another advantage is that, because an accounting is usually made after a surgical procedure, the inner envelope, the torn portion of the inner envelope, and the retainer label can be counted as one piece after direct dispensing of the surgical suture.
Still another advantage of the package of this invention is the textured surface of the sealed area. This allows for a secure grip, for example, by the thumb and index finger. Also, because of the textured surface, the amount of hand pressure which would have to be applied to the sealed area during tearing may be reduced.